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| Name | Class |
|---|---|
| Dalhousie University | OTHER |
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The purpose of this study is to evaluate a text message-based program called Essential Coaching for Every Mother which sends daily text messages during the immediate six-week postnatal period. Essential Coaching for Every Mother consists of standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health.
This is a 2-group parallel arm randomized controlled trial. Participants will be randomized into either the intervention or a control group, stratified by parity. No changes to in-person care will occur.
Mothers in the intervention group will receive daily text messages from enrollment after birth until six-weeks postpartum.
Mothers in the control group will receive no content messages.
Mothers will be recruited both antenatally and postnatally through social media and study posters. All recruitment and participant engagement will occur remotely via text message. Women who are 37+ weeks pregnant up to 10 days postpartum will be eligible to send a text to a study specific number and complete an eligibility screening. If determined eligible once they deliver, the participant will be randomized into the intervention or control group and they will be asked to complete an electronic consent form and the baseline survey. Participants in the intervention group will start receiving the Essential Coaching for Every Mother program based on their delivery date up to six weeks postpartum. Mothers in the control group will only receive reminder texts to complete the follow-up surveys. Both groups will be asked to complete an online survey at enrolment, six-weeks and six-months postpartum.
The investigators aim to recruitment 140 participants in total, 70 per group.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Essential Coaching for Every Mother Intervention | Experimental | Women in the intervention arm will receive the Essential Coaching for Every Mother messages up to six-weeks postpartum. No changes in standard care. |
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| Standard care | No Intervention | Women in the control group will receive no content messages. No changes in standard care. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Essential Coaching for Every Mother | Behavioral | Essential Coaching for Every Mother consists of 53 standardized text messages that provide evidence-based information that women should be aware of related to caring for their newborn and maternal mental health. Messages are personalized with the name of the child. Messages sent from birth to six-weeks postpartum, with two messages sent per day in the first two weeks and a daily message for weeks 3-6. The following topics covered in Essential Coaching for Every Mother include anxiety, depression, maternal self-care, postnatal follow-up, breastfeeding or formula feeding, infant concerns, cord care, well-baby care, normal development, crying, and safe sleep. Women who receive the messages will be able to self-select breastfeeding or formula feeding messages. |
| Measure | Description | Time Frame |
|---|---|---|
| Self Efficacy | Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy) | Change from enrolment (baseline) to six-weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Social support | Multidimensional Scale of Perceived Social Support (For the sub-scales of family, friends, and significant other [Minimum: 0, Maximum: 4]; for the total score, [Minimum: 0, Maximum: 12]; higher scores indicate greater support). | Change from enrolment (baseline) to six-weeks |
| Postpartum anxiety |
| Measure | Description | Time Frame |
|---|---|---|
| Implementation extent (Reach) | What was the reach (i.e., enrolment rate)? | Through study completion, an average of 1 year |
| Implementation extent (completion) | What was the completion rate (e.g., withdrawal rate)? |
Inclusion Criteria:
To enroll antenatally, participants must:
To enroll postnatally, participants must:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Justine Dol, MSc | Dalhousie University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| IWK Health | Halifax | Nova Scotia | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33764309 | Background | Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Effectiveness of a Postpartum Text Message Program (Essential Coaching for Every Mother) on Maternal Psychosocial Outcomes: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2021 Mar 25;10(3):e27138. doi: 10.2196/27138. | |
| 35559855 | Background |
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| ID | Term |
|---|---|
| D019052 | Depression, Postpartum |
| ID | Term |
|---|---|
| D011644 | Puerperal Disorders |
| D011248 | Pregnancy Complications |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
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The current study is a 2-group parallel arm randomized controlled trial, stratified by parity.
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Blinding is not possible for participants and thus participants will be informed of their group allocation.
To minimize personnel blinding related to data collection, no hospital staff (nurse midwives, physicians, other healthcare providers) are required to be aware of participant's involvement in the study. This is possible as Essential Coaching for Every Mother is sent to the participant's personal cell phone with no intervention occurring in person.
The PI will be aware of participant allocation and will be responsible for collecting data but will not be involved in the randomization procedure which occurs directly in the TextIt platform. Additionally, there is no interaction with the participants from the PI or anyone on the research team as everything occurs remotely via a previously set up process, reducing any risk of influencing participant response and influencing outcome assessment.
|
Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety) |
| Change from enrolment (baseline) to six-weeks |
| Postpartum depression | Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression) | Change from enrolment (baseline) to six-weeks |
| Self-Efficacy | Karitane Parenting Confidence Scale (Minimum: 0, Maximum: 45; Higher score indicates greater self-efficacy) | Change from six-weeks to six-months postpartum |
| Social Support | Multidimensional Scale of Perceived Social Support (For the sub-scales of family, friends, and significant other [Minimum: 0, Maximum: 4]; for the total score, [Minimum: 0, Maximum: 12]; higher scores indicate greater support). | Change from six-weeks to six-months postpartum |
| Postpartum anxiety | Postpartum Specific Anxiety Scale (Minimum: 51, Maximum: 204; Higher score indicates higher anxiety) | Change from six-weeks to six-months postpartum |
| Postpartum depression | Edinburgh Postnatal Depression Scale (Minimum: 0, Maximum: 30; Higher score indicates higher depression) | Change from six-weeks to six-months postpartum |
| Through study completion, an average of 6 weeks |
| Implementation extent (dose) | What was the dose received (i.e., number of messages received)? | Through study completion, an average of 6 weeks |
| Implementation quality | Qualitative feedback on program:
| 6-weeks postpartum |
| Dol J, Aston M, McMillan D, Tomblin Murphy G, Campbell-Yeo M. Participants' Perceptions of Essential Coaching for Every Mother-a Canadian Text Message-Based Postpartum Program: Process Evaluation of a Randomized Controlled Trial. JMIR Form Res. 2022 May 13;6(5):e36821. doi: 10.2196/36821. |
| 32475782 | Result | Dol J, Tomblin Murphy G, Aston M, McMillan D, Campbell-Yeo M. Design, development and usability testing of Essential Coaching for Every Mother: A postnatal text message educational intervention. Women Birth. 2021 May;34(3):e228-e236. doi: 10.1016/j.wombi.2020.05.004. Epub 2020 May 29. |
| D003866 | Depressive Disorder |
| D019964 | Mood Disorders |
| D001523 | Mental Disorders |